DIN EN ISO 19001:2013-07
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 / Note: DIN EN 12376 (1999-04) remains valid alongside this standard until 2016-02-29.
| Fecha edición: |
2013-07-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers, and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology. The requirements for information supplied by the manufacturer specified in this document are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology. |
| Keywords: | Biological|Colour|Definitions|Diagnosis|Diagnosis (medical)|Dyeing|Dyes|In vitro|Information|Information supplied by the manufacturer|Instructions for use|In-vitro diagnostic|Marking|Medical sciences|Microbiology|Product information|Reagents|Specification (approval) |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 19001:2013 Idéntica ISO 19001:2013 |
|
Reemplazo Normas |
Reemplaza a DIN EN 12376:1999-04 Reemplaza a DIN EN ISO 19001:2010-08 |
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